1. TYPES OF INSPECTIONS Comprehensive Abbreviated Preapproval (PAI)
Covers all aspects of FDA regulated processes and products.
Includes coverage of major areas of the company’s quality systems such as QSR or cGMPs
Abbreviated
Covers a specific area or explores a greater depth for a particular area. .
Includes coverage of one product or specific company operations or a subsystem of QSR or cGMP
Preapproval (PAI)
Covers preapproval processes for a product; two major components of a PAI.
Rigorous, scientific review of safety and efficacy data to support product approval and compliance evaluation of facilities
Directed
Usually a response to product failure or contamination
Includes coverage of conditions that led to this violation